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Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12) (IMRT-HIT-SNT)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Heidelberg University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01220752
First Posted: October 14, 2010
Last Update Posted: April 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Heidelberg Ion Therapy Centre (HIT), Heidelberg, Germany
Information provided by:
Heidelberg University
  Purpose
The IMRT-HIT-SNT trial is a prospective, mono-centric, phase II trial evaluating toxicity and efficacy in the combined treatment with intensity-modulated radiation therapy (IMRT) and carbon ion (C12) boost. Primary endpoint is mucositis ≥ CTC°3, secondary endpoints are local control, disease-free survival, overall survival, and toxicity. Planned accrual of the trial includes 36 patients with histologically proven (≥R1-resected or inoperable) sinonasal malignancies.

Condition Intervention Phase
Sinonasal Malignancies: Adenocarcinoma and Squamous Cell Carcinoma of the Paranasal Sinuses Radiation: carbon ion boost Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Malignant Sinonasal Tumours With Intensity-modulated Radiotherapy (IMRT) and Carbon Ion Boost (C12)

Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • mucositis CTC grade 3 [ Time Frame: 6-8 weeks post completion of treatment ]
    Incidence of mucositis ≥ CTC°III will be assessed as the primary endpoint of the trial at completion of radiation therapy


Secondary Outcome Measures:
  • local control [ Time Frame: 2 years post completion of RT ]
  • disease-free survival [ Time Frame: 2 years post completion of RT ]
  • overall survival [ Time Frame: 2 years post completion of RT ]
  • acute toxicity CTC grade 1/2 [ Time Frame: within 90 days of RT ]
  • late toxicity [ Time Frame: from 90 days to trial completion ]

Estimated Enrollment: 30
Study Start Date: November 2010
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMRT + carbon ion boost
(8 x 3 GyE) carbon ion therapy followed by 50 Gy IMRT (2 Gy/ Fx)corresponding to a total dose of approximately 74 GyE.
Radiation: carbon ion boost
8 fractions carbon ion (8 x 3 GyE C12) therapy followed by 25 fractions of IMRT corresponding to a total dose of approximately 74 GyE. Treatment duration is approximately 61/2-7 weeks

Detailed Description:

Local control in sinonasal malignancies is dose dependent. However, dose escalation at acceptable toxicity is technically demanding even with modern radiotherapy techniques. Raster-scanned carbon ion therapy with highly conformal dose distributions may allow higher doses at comparable or reduced side-effects.

Methods/ design:

The IMRT-HIT-SNT trial is a prospective, mono-centric, phase II trial evaluating toxicity in the combined treatment with intensity-modulated radiation therapy (IMRT) and carbon ion (C12) boost in 36 patients with histologically proven (≥R1-resected or inoperable) adeno-/ or squamous cell carcinoma of the nasal cavity or paransal sinuses. Patients receive 24 GyE carbon ions (8 fractions) and IMRT (2.0 Gy/ fraction).

Study objectives:

Incidence of mucositis ≥ CTC°3 will be assessed as the primary endpoint of the trial, local control, disease-free survival, overall survival, and toxicity (incl. mucositis CTC °I-II and late toxicity at 2 years post RT)are secondary endpoints.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed or surgically removed adenocarcinoma or squamous cell carcinoma of the nasal cavity or paranasal sinuses
  • Inoperable tumour or refusal to undergo surgical resection
  • Macroscopic or microscopic residual tumour (R2/ R1) or
  • ≥T3/T4 or
  • written informed consent
  • pts aged 18 - 80 years
  • effective contraception for pts in childbearing age (<12 months post beginning of menopause)

Exclusion Criteria:

  • Prior radio- or chemotherapy for tumours of the head and neck
  • Other previous malignancy within the past 5 years except prior, adequately treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
  • Significant neurological or psychiatric condition including dementia or seizures or other serious medical condition prohibiting the patient's participation in the trial by judgement of the investigators
  • Legal incapacity or limited legal capacity
  • Positive serum/ urine beta-HCG/ pregnancy
  • Drug abuse
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220752


Contacts
Contact: Jürgen Debus, MD PhD +49-6221-56- ext 8202 juergen.debus@med.uni-heidelberg.de
Contact: Marc W Muenter, MD +49-6221-56 ext 8202 marc.muenter@med.uni-heidelberg.de

Locations
Germany
Dept of Radiation Oncology, University of Heidelberg, INF 400 Recruiting
Heidelberg, Germany, 69120
Contact: Alexandra D Jensen, MD, MSc    +49-6221-56 ext 8202    alexandra.jensen@med.uni-heidelberg.de   
Sponsors and Collaborators
Heidelberg University
Heidelberg Ion Therapy Centre (HIT), Heidelberg, Germany
Investigators
Principal Investigator: Juergen Debus, MD PhD Heidelberg University
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Dr. J. Debus, Dept. of Radiation Oncology, University of Heidelberg, INF 400, 69120 Heidelberg, Germany
ClinicalTrials.gov Identifier: NCT01220752     History of Changes
Other Study ID Numbers: IMRT-HIT-SNT
First Submitted: October 12, 2010
First Posted: October 14, 2010
Last Update Posted: April 24, 2013
Last Verified: April 2013

Keywords provided by Heidelberg University:
IMRT
carbon ion therapy
paranasal sinus
nasal cavity
adenocarcinoma
squamous cell carcinoma

Additional relevant MeSH terms:
Paranasal Sinus Neoplasms
Carcinoma, Squamous Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Nose Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nose Diseases
Respiratory Tract Diseases
Paranasal Sinus Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases